Phase I Study to evaluate safety and tolerability of PRO-230 (atropine sulphate 0.05%) ophthalmic solution through evaluation of incidence of non-expected adverse events (AE), photophobia, pupillary diameter, incidence of expected adverse events, and best near corrected visual acuity (BNCVA)
A total of 29 healthy volunteers will apply PRO-230 ocular solution on both eyes QD (one time per day) for 14 days. The safety variables will include non expected AE, pupillary diameter and expected AE; tolerability variables will include incidence of photofobia, and BNCVA. Exploratory variables include best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal an conjunctival staining with fluorescein and lissamine green, vital signs (heart rate and blood pressure), and results of the Ocular Confort Index (OCI) questionnaire. The presence of non-expected AE \< 10% will deem PRO-230 as safe; while an incidence of photophobia \< 30% will deem PRO-230 as tolerable.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Atropine Sulfate 0.05% Ophthalmic Solution
Incidence of unexpected adverse events
The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
Time frame: Through Day 21 ± 1 (Safety Call)
Incidence of photophobia
The number of cases of photophobia.
Time frame: Through Day 21 ± 1 (Safety Call)
Pupillary Diameter
Change of pupillary diameter after exposure to the investigation product.
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]
Incidence of expected adverse events
The number of adverse events presented that are previously described / known for the active substance in this pharmaceutic form and concentration.
Time frame: Through Day 21 ± 1 (Safety Call)
Measurement of the change in best near corrected visual acuity (BNCVA)
The change in BNCVA after exposure to investigation product, compared to basal value.
Time frame: Time Frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
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